Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX SD, TD & S/T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX ST/JT, SETROX S & DEXTRUS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Tryton Side Branch Stent

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·HULKA CLIP FOR TUBAL OCCLUSION

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity, RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS® Total Knee System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEDOLYTIC THROMBECTOMY SYSTEM CORONARY USE

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ESSURE SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance Cardiac Cryoablation Catheters

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·INSPIRE PROGRAMMER SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS® Total Knee System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Gelsyn-3

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Endobronchial Valve System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Revanesse Versa, Revanesse Versa+ and Revanesse Lips+

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF (GRAFTSKIN)

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC